Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT03855202
Status:
UNKNOWN
Last Update Posted:
2019-02-26
First Post:
2019-02-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Treatment of Bronchopulmonary Dysplasia by Instillation PS and Mononuclaer Cells in Preterms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-02-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2020-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-24', 'studyFirstSubmitDate': '2019-02-24', 'studyFirstSubmitQcDate': '2019-02-24', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients who died', 'timeFrame': 'up to 21 days after birth', 'description': 'mority rate'}], 'secondaryOutcomes': [{'measure': 'number of patients with neurodevelopmental disorder assessed by Bayley Score', 'timeFrame': 'up to 1 month, 3 month, 6 months and 1 year', 'description': 'Long term follow up:in 1 month, 3months,6 months,and 1 years:'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PS', 'cord blood mononuclaer Cells', 'preterm'], 'conditions': ['Neonates Premature', 'Ventilator Support']}, 'descriptionModule': {'briefSummary': 'Bronchopulmonary dysplasia mainly occurs in premature infants, which is the main cause of premature infant death.If children with BPD can survive, they are also prone to complications of long-term respiratory diseases such as asthma,that affect the quality of life of BPD children. However, there is no effective treatment method for BPD. So,the investigator would like to investigate the effect of Intratracheal PS and mononuclaer cells in pretems', 'detailedDescription': 'This is a Phase 1 clinical trial that constitues one time points cohor and three group,each group with 80 participants,which receive intratracheal PS and mononuclaer cells,receive intratracheal PS,receive intratracheal mononuclaer cells.\n\n1. Eligibility Criteria:Preterm(gestational age more than 28weeks and less than 37weeks)\n2. Exlusion criteria: Preterm infants with major congenital malformations,chromosomal anomalies,inborn errors of metabolism and clinical or laboratory evidence of a congenital infection\n3. Demographic Data and Baseline characteristics of the study groups were collected:\n\nGestational age(weeks) birth weight(g) gender Cesarean section delivery antenatal steroids prolonged rupture of membrane Multiple pregnancies APGAR score at 5 minutes Thrombocytopenia before intervention CRP befor intervention(mg/l) TNF-αbefore intervention（pg/ml） 4.Autologous cord blood mononuclear cells doses is 25million cells/kg 5.the following are monitored at 3、7、14、21 days after birth: mortality, incidence of bronchopulmonary dysplasia 5.Long-term follow up:in 1m，3m，6m,1y:neurodevelopment,asthma，anemia and physic growth'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Weeks', 'minimumAge': '28 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ntwenty-eight weeks to thirty-seven weeks\n\nExclusion Criteria:\n\nPretem infants with major congenital malformations,chromosomal anomalies,inborn errors of metabolism and clinical or laboratory evidence of a congenital infection'}, 'identificationModule': {'nctId': 'NCT03855202', 'acronym': 'BPD', 'briefTitle': 'The Treatment of Bronchopulmonary Dysplasia by Instillation PS and Mononuclaer Cells in Preterms', 'organization': {'class': 'OTHER', 'fullName': 'Guangdong Women and Children Hospital'}, 'officialTitle': 'The Treatment of Bronchopulmonary Dysplasia by Instillation PS and Mononuclaer Cells in Preterms', 'orgStudyIdInfo': {'id': 'Guangdong W C H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'infusion froup 1', 'description': 'autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg', 'interventionNames': ['Biological: CBMNC']}, {'type': 'EXPERIMENTAL', 'label': 'infusion group 2', 'description': 'autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg', 'interventionNames': ['Biological: PS+CBMNC']}, {'type': 'EXPERIMENTAL', 'label': 'infusion group 3', 'description': 'PS,dose is 70mg/kg', 'interventionNames': ['Biological: PS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebol', 'description': '0.9% sodium chloride installation after 24 hours', 'interventionNames': ['Other: Placeo']}], 'interventions': [{'name': 'CBMNC', 'type': 'BIOLOGICAL', 'description': 'autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg', 'armGroupLabels': ['infusion froup 1']}, {'name': 'PS+CBMNC', 'type': 'BIOLOGICAL', 'description': 'autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg', 'armGroupLabels': ['infusion group 2']}, {'name': 'PS', 'type': 'BIOLOGICAL', 'description': 'PS,dose is 70mg/kg', 'armGroupLabels': ['infusion group 3']}, {'name': 'Placeo', 'type': 'OTHER', 'description': '0.9% sodium chloride installation after 24 hours', 'armGroupLabels': ['Placebol']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhuxiao Ren, MD', 'role': 'CONTACT', 'email': 'renzhx1990@163.com', 'phone': '+8613538984634'}], 'overallOfficials': [{'name': 'Jie Yang, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Guangdong Women and Children Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'yangjie', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Dept of Neonatology', 'investigatorFullName': 'yangjie', 'investigatorAffiliation': 'Guangdong Women and Children Hospital'}}}}